Recruiting

ZBPro

Sponsor:

ZBeats INC

Code:

NCT06013917

Conditions

Arrhythmias, Cardiac

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cardiac Monitoring

Study Details

Brief summary:

The proposed research is to address the accessibility and affordability of technology to capture symptomatic and asymptomatic cardiac events via Long-Term Continuous Electrocardiogram Monitoring (LTCM), and to provide physicians with full access to their patients' recorded data in a timely manner. We adopt an FDA cleared single- lead OEM patch Holter made of flexible material to make long-term wearing more comfortable and more patient compliant. The patch transmits the recorded data to our cloud-based platform: ZBPro™, where our innovative technologies reside. Our proprietary AI algorithms with innovative human interaction tools, which were developed under the National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase I (Award #: 2025951) Award analyze and interpret the recorded data to detect and annotate arrhythmia/cardiac events, and generates daily reports for physician review. The feasibility of our algorithms has been verified using ZBeats' proprietary ECG database based on the standard ANSI/AAMI EC57. Data collection and transmission has been verified in the office environment.

This proposed observational study will utilize a multidisciplinary collaboration of ZBeats Inc. (ZBTS), Stony Brook University (SBU), and Lankenau Medical Center (LMC). The study will enroll patients undergoing ECG monitoring. The primary outcome measure will be the ability to capture cardiac arrhythmias and events from participants. The prescribed FDA-cleared device will serve as the ground truth (GT) for our analyses. The detected arrhythmias and events from our solution will be compared with the findings from the ground truth to obtain our system's detection rate. The goal is to achieve a detection rate of >80% to be deemed successful.

Conditions

Arrhythmias, Cardiac

Study ID

NCT06013917

Start date

Aug 30, 2023

Status verified date

Sep, 2023

Completion date

May, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Patients who are > 18 years of age
2. Patients who are from one of the clinical collaborators practices
3. Patients who are prescribed to undergo ECG monitoring using an FDA-cleared monitoring device
4. Patients who are post TAVR procedure, a recent history of stroke/TIA, or having cardiac related symptoms
5. Patients who are comfortable using a smartphone or have someone in the home to help with data transmission
6. Patients who have manual dexterity to be able to recharge the phone battery or someone in the home to help them
7. Patients who are English speaking

Exclusion Criteria:

1. Patients who are <18 years of age
2. Patients who are not being prescribed with cardiac monitor testing
3. Patients who refuse to sign informed consent
4. Patients who are unable to provide informed consent
5. Patients who have a pacemaker implanted
6. Patients who are presenting with any dermatitis or infected skin over left anterior thorax
7. Patients who have a history of reaction to a prior cardiac monitor device
8. Patients who are uncomfortable having a cell phone at home for the duration of study participation
9. Patients who non-English speaking

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients on ECG monitoring post-transcatheter aortic valve replacement (TAVR) or other cardiac event

Patients at our clinical collaborators practices who have undergone TAVR or other cardiac event and who are placed on ECG monitoring will be placed on an FDA cleared cardiac monitor. We adopt an FDA cleared, reusable, single-lead OEM patch Holter made of flexible material to make long-term wearing more comfortable and more patient compliance.

Interventions

Cardiac Monitoring

FDA cleared ECG monitoring device that will be used to obtain ECG recordings and capture cardiac arrhythmias/events from participants

Primary outcome measure

  • Capturing cardiac arrhythmias and events [ Time Frame: 7 days after intervention ]

Central Contacts and Locations

Central contacts

Bin Fang, PhD

6312202463bin.fang@zbeats.co

Ashutosh Yaligar, MBA

5182219417ashutosh.yaligar@zbeats.co

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794

More Information

Sponsor

ZBeats INC

Last update posted

Sep 26, 2023

Last verified

Sep, 2023

Keywords

  • Artificial Intelligence
  • Cardiac Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ZBeats INC on 2023-09-26.